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Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy

Primary Purpose

Non-proliferative Diabetic Retinopathy

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Intravitreal Bevacizumab IVB
Follow-up with regular examination for determination of DR progression
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-proliferative Diabetic Retinopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presence of severe NPDR with DRSS score more than 53 with or without diabetic macular edema
  • Diagnosis of DM (type 1 or 2) with age more than 18 years' old
  • Visual acuity from 20/25 to 20/40 according to Snellen chart examination or more than 69 letters according to ETDRS chart

Exclusion Criteria:

  • Presence of proliferative diabetic retinopathy features including vitreous hemorrhage or optic disc or retinal neovascularization
  • History of retinal laser photocoagulation
  • Tractional retinal detachment involving the macula
  • Evidence of neovascularization of angle on examination
  • Macular edema due to a cause other than DME
  • Any ocular condition which may change visual acuity during the study
  • History of intravitreal injection of anti-vascular endothelial growth factor agent in past 3 months
  • History of any use of intravitreal corticosteroid
  • History of major intra-ocular surgery except cataract surgery in the past 6 months
  • History of thromboembolic every in the past 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Intravitreal Bevacizumab IVB group

    undergo regular follow-up for Diabetic Retinopathy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging
    Multiple fundus photographs interpreted by a single vitreoretinal surgeon who is blind to the study groups

    Secondary Outcome Measures

    Best corrected visual acuity
    Best corrected visual acuity based on ETDRS letter scale and logMAR
    Central retinal thickness
    Central retinal thickness according to macular ocular coherence tomography
    Number of visits
    Number of visits in each time point

    Full Information

    First Posted
    August 11, 2020
    Last Updated
    August 12, 2020
    Sponsor
    Shahid Beheshti University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04511715
    Brief Title
    Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy
    Official Title
    Efficacy and Safety of Intravitreal Bevacizumab for the Improvement of Severe Non-proliferative Diabetic Retinopathy Without DME: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    January 1, 2021 (Anticipated)
    Study Completion Date
    November 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shahid Beheshti University of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In this randomized clinical trial, 100 eyes with nonproliferative diabetic retinopathy will be included and divided randomly into 2 groups: Intravitreal Bevacizumab group (50 eyes) that receive 6 bimonthly intravitreal bevacizumab, and control group (50 eyes) that undergo regular follow-up for Diabetic Retinopathy. Diabetic macular edema (DME) will be treated independently in all groups by intravitreal bevacizumab. Primary outcome will be the percentage of patients with progression of 2 or more stages through international diabetic retinopathy staging. The secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-proliferative Diabetic Retinopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravitreal Bevacizumab IVB group
    Arm Type
    Active Comparator
    Arm Title
    undergo regular follow-up for Diabetic Retinopathy
    Arm Type
    Sham Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Intravitreal Bevacizumab IVB
    Intervention Description
    Intravitreal Bevacizumab IVB group (50 eyes) that receive 6 bimonthly IVBs within a period of 10 months following the enrollment
    Intervention Type
    Other
    Intervention Name(s)
    Follow-up with regular examination for determination of DR progression
    Intervention Description
    regular examination for determination of DR progression
    Primary Outcome Measure Information:
    Title
    Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging
    Description
    Multiple fundus photographs interpreted by a single vitreoretinal surgeon who is blind to the study groups
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Best corrected visual acuity
    Description
    Best corrected visual acuity based on ETDRS letter scale and logMAR
    Time Frame
    12 months
    Title
    Central retinal thickness
    Description
    Central retinal thickness according to macular ocular coherence tomography
    Time Frame
    12 months
    Title
    Number of visits
    Description
    Number of visits in each time point
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Presence of severe NPDR with DRSS score more than 53 with or without diabetic macular edema Diagnosis of DM (type 1 or 2) with age more than 18 years' old Visual acuity from 20/25 to 20/40 according to Snellen chart examination or more than 69 letters according to ETDRS chart Exclusion Criteria: Presence of proliferative diabetic retinopathy features including vitreous hemorrhage or optic disc or retinal neovascularization History of retinal laser photocoagulation Tractional retinal detachment involving the macula Evidence of neovascularization of angle on examination Macular edema due to a cause other than DME Any ocular condition which may change visual acuity during the study History of intravitreal injection of anti-vascular endothelial growth factor agent in past 3 months History of any use of intravitreal corticosteroid History of major intra-ocular surgery except cataract surgery in the past 6 months History of thromboembolic every in the past 3 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Homayon Nikkhah, MD
    Phone
    009822591616
    Email
    labbafi@hotmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy

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